The ICH Q2 revision expands validation criteria for multivariate analytical methods and biotech products. We translate what that means at the bench.
The ICH Q2(R2) revision consolidates decades of regulatory practice and responds to the reality of modern analytical methods — including spectroscopy, quantitative PCR and cell-based assays.
In practice, that means designing the validation plan from the product's risk profile, not merely replicating static criteria. Coverage of linearity, specificity, robustness and range must be justified.
Our analytical engineering rewrites legacy protocols under the new ICH Q2(R2) logic, reducing rework at ANVISA, FDA and EMA.